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FDA 510(k)

NeuMoDx GBS Assay

K-Number: K173725 · 2018-06-26

ApplicantNeumodx Molecular, Inc.
Decision Date2018-06-26
Product CodeNJR
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

NeuMoDx GBS Assay is the device name listed in this FDA 510(k) record. The listed applicant is Neumodx Molecular, Inc.. It received FDA 510(k) clearance on 2018-06-26 under 510(k) number K173725. The device is classified under product code NJR. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NeuMoDx GBS Assay?

NeuMoDx GBS Assay is a medical device that received FDA 510(k) clearance on 2018-06-26. The listed applicant is Neumodx Molecular, Inc.. The 510(k) number is K173725.

When did NeuMoDx GBS Assay receive FDA 510(k) clearance?

NeuMoDx GBS Assay received FDA 510(k) clearance on 2018-06-26, under 510(k) number K173725.

Who is the listed applicant for NeuMoDx GBS Assay?

The FDA 510(k) record lists Neumodx Molecular, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NeuMoDx GBS Assay?

The FDA product code for NeuMoDx GBS Assay is NJR.

Other records listing Neumodx Molecular, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K230267NeuMoDx CT/NG Assay 2.0

Related Devices (Code: NJR)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K222638Xpert® Xpress GBS, GeneXpert® Dx System, GeneXpert® Infinity SystemsCepheidK203429Xpert GBS LB XC, GeneXpert Dx System, GeneXpert Infinity SystemCepheidK182467Simplexa GBS Direct, Simplexa GBS Positive Control PackDiasorin Molecular, LLCK181156Panther Fusion GBS AssayDiagenodeK173250Solana GBS AssayQuidel CorporationK170557GenePOC GBS LBGenepoc, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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